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Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma (BUS255)

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ClinicalTrials.gov Identifier: NCT00424515
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mucosal Melanoma
Acral/Lentiginous Melanoma
Chronically Sun Damaged Melanomas
Intervention Drug: Imatinib
Enrollment 24
Recruitment Details The study was activated on July 6, 2006 and closed March 1, 2011. Patients enrolled from 9 medical centers beginning April 2007 through December 2010.
Pre-assignment Details  
Arm/Group Title Amplified KIT Mutated KIT
Hide Arm/Group Description Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status. Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
Period Title: Overall Study
Started 11 13
Completed 0 0
Not Completed 11 13
Reason Not Completed
Progressive Disease             10             11
Adverse Event             0             1
Intercurrent Illness             0             1
Withdrawal by Subject             1             0
Arm/Group Title Amplified KIT Mutated KIT Total
Hide Arm/Group Description Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status. Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status. Total of all reporting groups
Overall Number of Baseline Participants 11 13 24
Hide Baseline Analysis Population Description
The analysis dataset is comprised of enrolled and treated patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 13 participants 24 participants
69
(55 to 84)
64
(42 to 80)
65
(42 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 13 participants 24 participants
Female
7
  63.6%
11
  84.6%
18
  75.0%
Male
4
  36.4%
2
  15.4%
6
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 13 participants 24 participants
11 13 24
Melanoma Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 13 participants 24 participants
Acral 4 2 6
Mucosal 6 11 17
Chronically Sun-Damaged 1 0 1
1.Primary Outcome
Title Best Overall Response
Hide Description Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.
Time Frame Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of treated patients.
Arm/Group Title Amplified KIT Mutated KIT
Hide Arm/Group Description:
Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
Overall Number of Participants Analyzed 11 13
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0
Partial Response 0 7
Stable Disease 2 3
Progressive Disease 9 3
2.Secondary Outcome
Title Time to Progression
Hide Description Time to progression (TTP) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Time Frame Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of treated patients.
Arm/Group Title Amplified KIT Mutated KIT
Hide Arm/Group Description:
Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
Overall Number of Participants Analyzed 11 13
Median (95% Confidence Interval)
Unit of Measure: months
3.4
(1.0 to 5.7)
3.9
(2.6 to 6.6)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) is defined as the time from study entry to death or date last known alive.
Time Frame Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of treated patients.
Arm/Group Title Amplified KIT Mutated KIT
Hide Arm/Group Description:
Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
Overall Number of Participants Analyzed 11 13
Median (95% Confidence Interval)
Unit of Measure: months
11.9
(4.5 to 16.2)
12.9
(5.5 to 24.3)
Time Frame AE assessment occurred every other month from the start of study drug and up to day 30 post-treatment.
Adverse Event Reporting Description Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
 
Arm/Group Title Amplified KIT Mutated KIT
Hide Arm/Group Description Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status. Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
All-Cause Mortality
Amplified KIT Mutated KIT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amplified KIT Mutated KIT
Affected / at Risk (%) Affected / at Risk (%)
Total   1/11 (9.09%)   3/13 (23.08%) 
Blood and lymphatic system disorders     
Hemoglobin  1  0/11 (0.00%)  2/13 (15.38%) 
Investigations     
Leukocytes  1  0/11 (0.00%)  1/13 (7.69%) 
Lymphopenia  1  1/11 (9.09%)  1/13 (7.69%) 
Neutrophils  1  0/11 (0.00%)  1/13 (7.69%) 
Metabolism and nutrition disorders     
Hypokalemia  1  0/11 (0.00%)  1/13 (7.69%) 
Skin and subcutaneous tissue disorders     
Pruritus/itching  1  0/11 (0.00%)  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amplified KIT Mutated KIT
Affected / at Risk (%) Affected / at Risk (%)
Total   9/11 (81.82%)   13/13 (100.00%) 
Blood and lymphatic system disorders     
Hematologic  1  0/11 (0.00%)  1/13 (7.69%) 
Hemoglobin  1  3/11 (27.27%)  3/13 (23.08%) 
Lymphatics  1  1/11 (9.09%)  0/13 (0.00%) 
Eye disorders     
Ocular  1  0/11 (0.00%)  1/13 (7.69%) 
Optic disc edema  1  0/11 (0.00%)  1/13 (7.69%) 
Tearing  1  1/11 (9.09%)  1/13 (7.69%) 
Gastrointestinal disorders     
Abdomen, pain  1  0/11 (0.00%)  2/13 (15.38%) 
Constipation  1  0/11 (0.00%)  2/13 (15.38%) 
Diarrhea w/o prior colostomy  1  2/11 (18.18%)  7/13 (53.85%) 
Distention/bloating, abdominal  1  0/11 (0.00%)  1/13 (7.69%) 
Dry mouth  1  0/11 (0.00%)  1/13 (7.69%) 
Dyspepsia  1  1/11 (9.09%)  0/13 (0.00%) 
Flatulence  1  0/11 (0.00%)  2/13 (15.38%) 
GI  1  1/11 (9.09%)  3/13 (23.08%) 
Nausea  1  4/11 (36.36%)  8/13 (61.54%) 
Vomiting  1  2/11 (18.18%)  4/13 (30.77%) 
General disorders     
Constitutional  1  1/11 (9.09%)  1/13 (7.69%) 
Edema head and neck  1  1/11 (9.09%)  6/13 (46.15%) 
Edema limb  1  0/11 (0.00%)  7/13 (53.85%) 
Edema trunk/genital  1  0/11 (0.00%)  1/13 (7.69%) 
Fatigue  1  7/11 (63.64%)  7/13 (53.85%) 
Flu-like syndrome  1  0/11 (0.00%)  1/13 (7.69%) 
Rigors/chills  1  1/11 (9.09%)  1/13 (7.69%) 
Injury, poisoning and procedural complications     
Bruising  1  0/11 (0.00%)  1/13 (7.69%) 
Investigations     
ALT, SGPT  1  0/11 (0.00%)  2/13 (15.38%) 
AST, SGOT  1  0/11 (0.00%)  3/13 (23.08%) 
Bilirubin  1  1/11 (9.09%)  0/13 (0.00%) 
Creatinine  1  1/11 (9.09%)  1/13 (7.69%) 
Leukocytes  1  2/11 (18.18%)  1/13 (7.69%) 
Metabolic/Laboratory  1  1/11 (9.09%)  1/13 (7.69%) 
Neutrophils  1  2/11 (18.18%)  2/13 (15.38%) 
Platelets  1  0/11 (0.00%)  1/13 (7.69%) 
Weight loss  1  0/11 (0.00%)  1/13 (7.69%) 
Metabolism and nutrition disorders     
Anorexia  1  3/11 (27.27%)  2/13 (15.38%) 
Bicarbonate  1  0/11 (0.00%)  1/13 (7.69%) 
Hyperglycemia  1  0/11 (0.00%)  1/13 (7.69%) 
Hyperkalemia  1  0/11 (0.00%)  1/13 (7.69%) 
Hypernatremia  1  0/11 (0.00%)  1/13 (7.69%) 
Hypoalbuminemia  1  0/11 (0.00%)  2/13 (15.38%) 
Hypocalcemia  1  0/11 (0.00%)  2/13 (15.38%) 
Hypokalemia  1  0/11 (0.00%)  1/13 (7.69%) 
Hypomagnesemia  1  0/11 (0.00%)  1/13 (7.69%) 
Hyponatremia  1  0/11 (0.00%)  1/13 (7.69%) 
Nervous system disorders     
Dizziness  1  2/11 (18.18%)  2/13 (15.38%) 
Head/headache  1  1/11 (9.09%)  0/13 (0.00%) 
Taste disturbance  1  3/11 (27.27%)  1/13 (7.69%) 
Tremor  1  0/11 (0.00%)  1/13 (7.69%) 
Psychiatric disorders     
Insomnia  1  0/11 (0.00%)  1/13 (7.69%) 
Renal and urinary disorders     
Glomerular filtration rate  1  0/11 (0.00%)  1/13 (7.69%) 
Hemoglobinuria  1  1/11 (9.09%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/11 (0.00%)  2/13 (15.38%) 
Dyspnea  1  0/11 (0.00%)  3/13 (23.08%) 
Pleural effusion (non-malignant)  1  0/11 (0.00%)  1/13 (7.69%) 
Pulmonary/Upper Respiratory  1  0/11 (0.00%)  1/13 (7.69%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  0/11 (0.00%)  1/13 (7.69%) 
Dry skin  1  0/11 (0.00%)  1/13 (7.69%) 
Pruritus/itching  1  1/11 (9.09%)  3/13 (23.08%) 
Rash/desquamation  1  0/11 (0.00%)  4/13 (30.77%) 
Skin  1  0/11 (0.00%)  1/13 (7.69%) 
Sweating  1  0/11 (0.00%)  2/13 (15.38%) 
Ulceration  1  0/11 (0.00%)  1/13 (7.69%) 
Vascular disorders     
Flushing  1  0/11 (0.00%)  1/13 (7.69%) 
Vascular  1  0/11 (0.00%)  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: F. Stephen Hodi, MD
Organization: Dana-Farber Cancer Institute
Phone: 617.632.5053
EMail: Stephen_Hodi@dfci.harvard.edu
Layout table for additonal information
Responsible Party: F. Stephen Hodi, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00424515     History of Changes
Other Study ID Numbers: 06-056
First Submitted: January 18, 2007
First Posted: January 19, 2007
Results First Submitted: August 22, 2016
Results First Posted: December 8, 2016
Last Update Posted: December 8, 2016